BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3042140 · Received April 9, 2013

    Report

    Report Number
    2024168-2013-02099
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 1, 2005
    Report Date
    March 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF THE EVENT INDICATED AS OCCURRED IN 2005, THE BEST GUESS DATE OF OCCURRENCE WILL BE (B)(6) 2005. IT IS INDICATED THAT THE DEVICES ARE NOT RETURNING FOR EVALUATION. THIS INCIDENT REPORTED ONLY PATIENT EFFECTS WITH NO ALLEGATION OF A DEVICE ISSUE AND, AS SUCH, IS NOT ON ITS OWN AN INDICATION OF A PRODUCT DEFICIENCY. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW, PERFORMED VIA RETROSPECTIVE ANALYSIS OF 2918 CEREBRAL ANGIOGRAMS AND NEURO-INTERVENTIONAL PROCEDURES DONE WITHOUT PROPHYLACTIC ANTIBIOTICS. ALL THE PROCEDURES WERE PERFORMED AT A SINGLE INSTITUTION AND BY A SINGLE ENDOVASCULAR NEUROSURGEON OVER A 7-YEAR PERIOD. THE AIM OF THE REVIEW WAS TO DETERMINE THE RATE OF INFECTION ASSOCIATED WITH NEURO-ANGIOGRAPHIC PROCEDURES IN A CLINICAL SETTING IN WHICH PROPHYLACTIC ANTIBIOTICS ARE NOT ROUTINELY GIVEN. FOR THIS CASE, THE PATIENT PRESENTED WITH SUBARACHNOID HEMORRHAGE. HE UNDERWENT CRANIOTOMY AND CLIPPING OF A MIDDLE CEREBRAL ANEURYSM WITH AN UNCOMPLICATED HOSPITAL COURSE. HE HAD A CEREBRAL ANGIOGRAM FOR FOLLOW-UP AFTER CLIPPING; THE RIGHT FEMORAL ARTERY ACCESS SITE WAS CLOSED WITH A PERCLOSE PROGLIDE CLOSURE DEVICE. THREE WEEKS AFTER DISCHARGE, HE WAS DIAGNOSED WITH A SUPERFICIAL WOUND INFECTION INVOLVING THE FEMORAL ARTERY ACCESS SITE AND WAS TREATED EMPIRICALLY WITH ORAL ANTIBIOTICS WITH RESOLUTION OF THE INFECTION. THE PATIENT LATER EXPIRED AS A RESULT OF COMPLICATIONS FROM CANCER. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145465 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R